Aline LE BRETON

En résumé

Entreprises

• Becton & Dickinson Rx - Project Manager

  2011 - maintenant Project teams manager for the development and transfer to industrial site of Company's first injectable pharmaceutical drug products, until regulatory file submission.
  
  • Lead of analytics, manufacturing, engineering, R&D, RA, QA teams members.
  • French and US teams.
  • Strategy, planning, and budget management within overall development program.
  • Part of implementation of project management activity and tools.

• Becton & Dickinson - Technology Transfer Supervisor

  2009 - 2013 Project Teams manager and member for the industrial transfer and scale-up of Company's first injectable pharmaceutical drug products .
  
  • Creation of the Tech Transfer activity with US production site teams.
  • Execution of Company's first injectable pharmaceutical drug products process transfers.
  • Support to R&D department activities.
  • Hierarchical management and transversal (project) management of engineers and technicians. French and US teams.

• Becton & Dickinson - Regulatory Affairs Specialist

  2007 - 2009 RA team member for injectable pharmaceutical drug products development and registration.
  
  • Creation of the pharmaceutical RA activity with US RA team. Compliance to US and French regulations.
  • Preparation of Company's first pharmaceutical drug products registration files.
  • Transfer activities preparation (potential gaps assessment, recommendations to control and minimize).
  • Support to ANSM and FDA inspections.

• Patheon - Industrial Regulatory Affairs Project Manager

  2004 - 2006 RA team member for “Products” and “Facility” new projects. Miscellaneous pharmaceutical forms (solids, liquids).
  
  • “In” manufacturing transfer of a range of INNs on behalf of a customer.
  • Registration files preparation. Regulatory compliance support to customers.
  • Coordination of major changes in the manufacturing Site Master File. Compliance with French site regulation.
  • Transversal work with QA, manufacturing, engineering teams.

• Mylan - Regulatory Affairs Specialist

  SAINT PRIEST Cedex 2002 - 2004 Management of a product range of 45 INNs. Miscellaneous pharmaceutical forms (solids, liquids).
  
  • Coordination of the preparation of new marketing authorizations and variations applications. Registrations follow-up with authorities.
  • Regulatory compliance.
  • Merck training: Merck Project Management School.

• Mylan - Project Manager, Pharmaceutical Development

  SAINT PRIEST Cedex 2001 - 2002 Management and coordination of the development of injectable drug products (EU market).
  
  • Management of EU analytical and formulation development contract labs.
  • Registration files preparation.
  • Predevelopment work on high potential generic injectable drug products.

• Martin J&J MSD - Project Manager, Pharmaceutical Development

  2000 - 2001 Interim management and coordination of OTC products development (EU market).

Formations

• University Victor Segalen Bordeaux 2

  Bordeaux 1998 - 1999 DESS Pharmaceutical Development and Manufacture of Health Products
  
  Additional training at the Affairs Management Institute.
  

• University Victor Segalen Bordeaux 2

  Bordeaux 1995 - 1997 Biological and Medical Sciences Master: Extractive and structural chemistry
  
  Pharmacognosie

• University Victor Segalen Bordeaux 2

  Bordeaux 1992 - 1999 Pharmacist Doctorate Diploma
  
  Pharmacy Faculty - Formulation oriented Thesis (Dec. 1999): “Flash” disintegrating tablets: Experimental comparison of current disintegrating agents, highlight on new excipients and use in pharmaceutical formulations

Réseau

• Alexandre LE BRETON

• Anne-Laure LARRIVIERE

• Charles BIANCON

• Claire GAUTHIER

• Delphine BRISSAUD

• Delphine DERAIL

• Grégory CAPDEPUY

• Stamford SIDIBE

• Yi LIN